FDA Related News

Human Drugs

Workshop on Patient Experience Data

Federal Register notice: FDA announces a 12/13 virtual public workshop entitled Patient-Focused Drug Development: Workshop to Discuss Methodologic and...

Human Drugs

Boston Scientific Recalls Cryoablation Catheters

Boston Scientific recalls (Class 1) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula risks.

Medical Devices

LivaNova Sleep Apnea Device Meets Endpoints

LivaNova says its aura6000 obstructive sleep apnea treatment met the safety and efficacy endpoints in the OSPREY trial in adults.

FDA Needs Inspection Staff Recruitment Plan: GAO

GAO healthcare director Mary Denigan-Macauley says FDA needs a plan and a strategy for recruiting and retaining new facility inspectors.

Medical Devices

FDA Clears GEs Head-Only MRI Device

FDA clears a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only MRI scanner.

Medical Devices

QS Issues at American Contract

FDA warns Mechanicsville, VA-based American Contract Systems about Quality System Regulation violations in its manufacturing of sterile convenience ki...

Human Drugs

CGMP Violations in Zhejiang Qimei Records Review

FDA warns Chinas Zhejiang Qimei Cosmetic Co. about CGMP violations in its manufacturing of OTC drugs.

Biologics

Abeona Skin Disorder BLA Resubmission Accepted

FDA accepts for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), a gene therapy for patients with recessive dystro...

Human Drugs

Nuplazid Not Withdrawn Over Safety/Efficacy

Federal Register notice: FDA determines that Nuplazid (pimavanserin tartrate) tablet (equivalent 17 mg base) was not withdrawn due to safety or effect...

Federal Register

Workshop on Optimizing Real-World Evidence Use

Federal Register notice: FDA announces a 12/12 public workshop titled Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drug...